and HRPP specialist determines that the allegation may be substantiated and may involve serious or continuing noncompliance, the full IRB will convene and decide if further investigation is needed before corrective action is considered. If the allegation is sufficiently substantiated after the initial assessment and further investigation is not needed, the Board will allow the principal investigator to respond to the allegation either by meeting with the IRB or in writing before deciding on and directing corrective action, which may include suspension or termination of IRB approval.

If the IRB decides to pursue an investigation, the IRB Chair in conjunction with OSP staff will appoint an ad hoc subcommittee to conduct the investigation. The ad hoc subcommittee will consist of a minimum of three voting IRB members. OSP staff will also provide a letter to the individual against whom the allegation was raised (if the individual is not the principal investigator, staff will also notify the principal investigator of the project in question) notifying them of the investigation.

The ad hoc committee will gather information pertaining to the nature of the allegation, the approved IRB protocol, and the procedures followed in conducting the study. An IRB representative will interview the complainant or, in cases where the complainant requests anonymity, the individual who received the original allegation will interview the complainant. The ad hoc committee will also interview the principal investigator and, if applicable, anyone else against whom the allegation has been raised. Depending on the nature of the allegation/concern and the information collected during the interviews, the ad hoc committee may interview other individuals. In addition, the committee may examine research data, both published and unpublished; informed consent/assent forms; medical records; inclusion/exclusion criteria; and any other pertinent information. The ad hoc committee, in cases of a credible allegation of serious or continuing noncompliance, will have authority to request an interview with anyone related to the project or request any information about the project that is the subject of the allegation.

When the ad hoc committee determines that its investigation is done, it will prepare, with the assistance of the HRPP specialist, a summary report for the full IRB. The report may consist of a summary of the allegation, interview summaries, and copies of pertinent information or correspondence. The report may or may not include recommendations for IRB action.

The IRB will review the materials presented by the ad hoc committee at a convened meeting at which a quorum is present. The materials provided will include the summary report of the alleged noncompliance and any other relevant materials. The convened IRB determines whether to request additional information or whether to interview additional witnesses. The IRB may give the principal investigator of the project under review the opportunity to meet with the convened IRB before it takes final action.